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Works closely with the Head of Regulatory Affairs to drive business planning, ensure strategic and operational alignment across sub functions, and to deliver on business transformation part of Alexion’s integration with AstraZeneca, with a specific focus on R&D. This role will also be responsible for proactively supporting the Alexion Regulatory Affairs organization development and strategy, along with supporting key initiatives, meetings, and messages.. Business processes : manage and oversee the main business processes of the Alexion Regulatory Affairs team, included but not limited to budgeting, finance forecasting, resourcing, and communications.. Drive business transformation : support Leadership in required business transformation and change management as part of Alexion’s integration in AstraZeneca, particularly on R&D, facilitating bridgebuilding on key business areas.. serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.. Business partnership : represents Alexion Regulatory Affairs as business partner for Finance, Human Resources, and other Business areas, aligning with relevant internal stakeholders (e.g., other Business Operation leads/Chiefs of Staff) on key topics.

regulatory affairs

Senior Director, Business Planning & Operations, Regulatory Affairs This is what you will do:
The (Senior) Director, Business Planning & Operations, is responsible for managing business processes in the Alexion Regulatory Affairs team and is a member of the Alexion Regulatory Affairs Leadership Team (RALT). Works closely with the Head of Regulatory Affairs to drive business planning, ensure strategic and operational alignment across sub functions, and to deliver on business transformation part of Alexion’s integration with AstraZeneca, with a specific focus on R&D. This role will also be responsible for proactively supporting the Alexion Regulatory Affairs organization development and strategy, along with supporting key initiatives, meetings, and messages. You will be responsible for:
Business processes : manage and oversee the main business processes of the Alexion Regulatory Affairs team, included but not limited to budgeting, finance forecasting, resourcing, and communications.
Leadership facilitation : drive the planning of Leadership meetings and facilitate decision-making and execution, including monitoring objective progress and escalation of business-relevant risks/concerns.
Business strategic planning and monitoring : drive effective business planning across sub-teams in alignment with Alexion deliverables and organizational strategies, and monitor and report against performance milestones, metrics and/or KPIs.
Drive business transformation : support Leadership in required business transformation and change management as part of Alexion’s integration in AstraZeneca, particularly on R&D, facilitating bridgebuilding on key business areas.
Executive Office support: serves as Chief of Staff to the VP, Head of Alexion Regulatory Affairs, supporting internal and external engagement and managing activities as part of the function’s Executive Office.
Business partnership : represents Alexion Regulatory Affairs as business partner for Finance, Human Resources, and other Business areas, aligning with relevant internal stakeholders (e.g., other Business Operation leads/Chiefs of Staff) on key topics.
Daily business management: drive day-to-day activities related to the team’s activities and lead organization and communication of team activities (e.g., Town Halls).
Cross-R&D Alignment: drive alignment across R&D functions, coordinating with other Business. Planning & Operations Leads, Chief of Staff, and leadership team members to support goal planning and tracking, prep for key leadership meetings, and other cross-R&D initiatives. You will need to have: Profession
Minimum of 10 years of experience in the life sciences sector, both public and private sector.
Prior experience is business operations / management activities required.
Prior experience in advising and supporting Senior Regulatory Management teams on internal and external deliverables required.
Good knowledge and understanding of the regulatory and quality business in a pharmaceutical company.
Good knowledge of business operations areas (e.g., finance, resourcing, etc.).
Good knowledge and understanding of the changing global regulatory environment and impact in business.
Proven track-record in working across R&D to support organizational deliverables.
Superior communication and presentation skills in English, both verbal and written.
Strong R&D focus and holistic thinker with strong business perspective.
Ability to influence and develop a network across the Enterprise.
Promotes a culture of teamwork, improvement mindset and innovative thinking. Education
Advanced degree in life sciences or health-related discipline (Pharm.D., M.D. or others)
Supplementary education in life-sciences with a strong R&D management component (e.g., MSc)
Executive education or similar on R&D strategic management or business operations Date Posted
11-Apr-2024
Closing Date
30-Dec-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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